MAUDE Adverse Event Report: COOK INC COOK TPN TRIPLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number G03319

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: unknown.(b)(4).Patient required an additional procedure to replace the device.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a leak was identified on a cook tpn triple lumen tpn catheter set.The patient was being treated for a pre-bone graft assessment.The device was initially placed on (b)(6) 2018.On (b)(6) 2019, while accessing the device, the health care team noted that one lumen was accessible for blood collections.A second lumen (blue) showed slight resistance to injection, however, it yielded without forcing.When this lumen was accessed to be flushed, the health care team noted an audible noise.The patient's undergarments were wet, so a leak was suspected.A leak was noted on the catheter proximal, just above the "triangle" separator on the patient's side.A crack in the device was then suspected.As no repair kit was available, the catheter was immediately clamped with forceps to avoid the risk of air embolism.The patient was taken emergently to the operating room and the device was removed and replaced.The customer reports that no traction or any force was exerted on the catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding the use of the device has been requested, but is not available at this time.

Manufacturer Narrative

Product received on 21mar2019.Results code: appropriate term/code not available (4247) ¿ device occlusion.Investigation - evaluation a review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control, as well as a functional test and visual inspection of the returned device was conducted during the investigation.One device was returned by the complainant for investigation.A visual examination of the device noted a gap in the small lumen a #1 and the large lumen hub.The lumen appeared to be occluded, as a leak test determined that water was unable to be flushed through successfully.The customer¿s difficulty could not be recreated during the investigation, but the occlusion of the lumens may have contributed to the failure to identify suspected leaks.Additionally, a document-based investigation evaluation was performed.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record did not show any nonconformances that could have contributed to this incident.It should be noted that there was one other complaint reported for lot 7002013.It was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: suggested catheter maintenance: after catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by the physician.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgment.Heparin concentrations of 10 unites/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

• Brand Name: COOK TPN TRIPLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8408314
• MDR Text Key: 138397851
• Report Number: 1820334-2019-00661
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002033191
• UDI-Public: (01)00827002033191(17)190624(10)7002013
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2019
• Device Model Number: G03319
• Device Catalogue Number: C-TPNS-8.0T-90
• Device Lot Number: 7002013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR